Rheumatoid Arthritis Clinical Trial
Official title:
Remote Arthritis Disease Activity MonitoR (RADAR 1) - a Feasibility Study of Home-based Dried Blood Spot Use to Monitor an Inflammatory Marker in Rheumatoid Arthritis Patients.
It is important that patients who suffer from Rheumatoid Arthritis (RA) have their disease monitored at an early stage, as well as when it is established. Presently, if a patient is to be assessed by means of disease activity scores and blood tests, they must attend a hospital appointment, which can be difficult for patients who live far from the clinic. It would be beneficial to be able to monitor and reliably define and report a disease 'flare' at home. Quite often, by the time the patient attends for an appointment, flare ups have subsided. This study will evaluate the possibility for patients to take their own blood samples in the comfort of their own home, by transferring finger prick blood droplets to a dried blood spot sample (DBSS) card. Patients would then send the cards to the laboratory to test for clinically relevant protein markers. The feasibility of 'remote' monitoring of the patient's disease will be explored.
In an arthritis patient population living some distance from hospitals, collection of a
series of blood samples to monitor disease activity in a timely fashion is difficult. The
ability to monitor markers of inflammation, such as C-reactive protein (CRP) and gauge a
patient's response to treatments via disease activity score (i.e. DAS28-ESR) is not just
important in early stage disease but also in patients with established disease. Patients with
chronic disease tend to lose self-confidence in managing their condition and a substantial
proportion can suffer recurrent disease flare- ups. These flare-ups are costly in terms of
appointments with GP and specialist clinics and result in significant work disability.
Being able to reliably define and report a disease 'flare' in arthritis is currently
problematic as there are no objective measures available to the patient while at home. The
clear definition of a flare, as determined through blood testing would help justify an
increase in immunosuppressant dose or a course of steroids. Currently, patients make a visit
to their GP or hospital clinic, at 6 week intervals at best. In reality, this means that
opportunities to monitor CRP during an active 'flare' are often missed and an informed
intervention (medication adjustments) is not possible. Home monitoring is constrained by the
costs of making phlebotomists available to make frequent home visits to patients. Also for
markers which are unstable at ambient temperatures, blood samples need to be refrigerated and
rapidly transported to the laboratory for analysis.
Thus the ability for the patient to collect their own blood samples in their own home and
send these at ambient temperature to a laboratory would enable 'remote' and timely monitoring
of chronic disease. The investigators have recently completed an Arthritis Research UK funded
clinical study that demonstrated that a number of clinically relevant proteins related to
flares (i.e.?) were reliably collected, stored for less than three months and extracted from
dried blood spots (n=20 arthritis patients). The paper cards used to collect blood droplets
were pre-treated to stabilise proteins and minimise haemolysis contamination (caused by
bursting and breakdown of red blood cells). Our results across 20 arthritis patients revealed
that 90% recovery rates can be achieved from dried blood spot sample (DBSS) stored at room
temperature for 3 month (relative to a matched -20'C frozen plasma sample). The inflammation
marker proteins included C-reactive protein (CRP), tumour necrosis factor alpha and
Immunoglobulin G. Without pre-treatment of the DBSS paper, only 53% of these proteins are
recovered.
For the patient, use of DBSS means that GP and hospital visits to take blood and carry out
tests could be reduced. With minimal training, samples would be obtained simply at home by
the patient, over a six week period and then transported at room temperature using
conventional post. Proteins could then be analysed at a central lab. In the future, the
technology could accompany patient assessments of disease activity and complement ongoing
studies focused on wearable sensors to measure joint movement and stiffness (UU Data-glove
project).
For the hospital trust, use of this novel technology could obviate the need for patients to
attend the clinic for blood sampling. Soon after prescribing a new treatment, clinicians
could use DBSS to monitor treatment efficacy in reducing inflammation. This technology
therefore offers an earlier opportunity than currently available to titre dosage and switch
from ineffective drugs or treatments associated with adverse events. Furthermore, feedback of
the monitoring information provided by DBSS could be given to the patient, via for example
smartphone application, and has the potential to improve adherence to treatment plans.
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